Conventional mechanical ventilation versus high-frequency oscillatory ventilation for congenital diaphragmatic hernia. A randomized clinical trial (The VICI-trial)

Kitty G. Snoek, Irma Capolupo, Joost Van Rosmalen, Lieke De Jongste-Van Den Hout, Sanne Vijfhuize, Anne Greenough, René M. Wijnen, Dick Tibboel, Irwin K M Reiss, Alessandra Di Pede, Andrea Dotta, Pietro Bagolan, Ulrike Kraemer, Carla Pinto, Maria Gorett Silva, Joana Saldanha, Prashanth Bhat, Vadivelam Murthy, Arno Van Heijst, Thomas SchaibleLucas Wessel, Karel Allegaert, Anne Debeer

Research output: Contribution to journalArticle

Abstract

Objectives: To determine the optimal initial ventilation mode in congenital diaphragmatic hernia. Background: Congenital diaphragmatic hernia is a life-threatening anomaly with significant mortality and morbidity. The maldeveloped lungs have a high susceptibility for oxygen and ventilation damage resulting in a high incidence of bronchopulmonary dysplasia (BPD) and chronic respiratory morbidity. Methods: An international, multicenter study (NTR 1310), the VICI-trial was performed in prenatally diagnosed congenital diaphragmatic hernia infants (n = 171) born between November 2008 and December 2013, who were randomized for initial ventilation strategy. Results: Ninety-one (53.2%) patients initially received conventional mechanical ventilation and 80 (46.8%) high-frequency oscillation. Forty-one patients (45.1%) randomized to conventional mechanical ventilation died/had BPD compared with 43 patients (53.8%) in the high-frequency oscillation group. An odds ratio of 0.62 [95% confidence interval (95% CI) 0.25-1.55] (P = 0.31) for death/BPD for conventional mechanical ventilation vs highfrequency oscillation was demonstrated, after adjustment for center, head-lung ratio, side of the defect, and liver position. Patients initially ventilated by conventional mechanical ventilation were ventilated for fewer days (P = 0.03), less often needed extracorporeal membrane oxygenation support (P = 0.007), inhaled nitric oxide (P=0.045), sildenafil (P=0.004), had a shorter duration of vasoactive drugs (P = 0.02), and less often failed treatment (P = 0.01) as compared with infants initially ventilated by high-frequency oscillation. Conclusions: Our results show no statistically significant difference in the combined outcome of mortality or BPD between the 2 ventilation groups in prenatally diagnosed congenital diaphragmatic hernia infants. Other outcomes, including shorter ventilation time and lesser need of extracorporeal membrane oxygenation, favored conventional ventilation.

Original languageEnglish
Pages (from-to)867-874
Number of pages8
JournalAnnals of Surgery
Volume263
Issue number5
DOIs
Publication statusPublished - 2016

Fingerprint

High-Frequency Ventilation
Artificial Respiration
Ventilation
Bronchopulmonary Dysplasia
Randomized Controlled Trials
Extracorporeal Membrane Oxygenation
Morbidity
Lung
Mortality
Multicenter Studies
Congenital Diaphragmatic Hernias
Nitric Oxide
Odds Ratio
Head
Confidence Intervals
Oxygen
Liver
Incidence
Pharmaceutical Preparations

Keywords

  • Congenital diaphragmatic hernia
  • Conventional mechanical ventilation
  • High-frequency oscillation

ASJC Scopus subject areas

  • Surgery

Cite this

Conventional mechanical ventilation versus high-frequency oscillatory ventilation for congenital diaphragmatic hernia. A randomized clinical trial (The VICI-trial). / Snoek, Kitty G.; Capolupo, Irma; Van Rosmalen, Joost; De Jongste-Van Den Hout, Lieke; Vijfhuize, Sanne; Greenough, Anne; Wijnen, René M.; Tibboel, Dick; Reiss, Irwin K M; Di Pede, Alessandra; Dotta, Andrea; Bagolan, Pietro; Kraemer, Ulrike; Pinto, Carla; Silva, Maria Gorett; Saldanha, Joana; Bhat, Prashanth; Murthy, Vadivelam; Van Heijst, Arno; Schaible, Thomas; Wessel, Lucas; Allegaert, Karel; Debeer, Anne.

In: Annals of Surgery, Vol. 263, No. 5, 2016, p. 867-874.

Research output: Contribution to journalArticle

Snoek, KG, Capolupo, I, Van Rosmalen, J, De Jongste-Van Den Hout, L, Vijfhuize, S, Greenough, A, Wijnen, RM, Tibboel, D, Reiss, IKM, Di Pede, A, Dotta, A, Bagolan, P, Kraemer, U, Pinto, C, Silva, MG, Saldanha, J, Bhat, P, Murthy, V, Van Heijst, A, Schaible, T, Wessel, L, Allegaert, K & Debeer, A 2016, 'Conventional mechanical ventilation versus high-frequency oscillatory ventilation for congenital diaphragmatic hernia. A randomized clinical trial (The VICI-trial)', Annals of Surgery, vol. 263, no. 5, pp. 867-874. https://doi.org/10.1097/SLA.0000000000001533
Snoek, Kitty G. ; Capolupo, Irma ; Van Rosmalen, Joost ; De Jongste-Van Den Hout, Lieke ; Vijfhuize, Sanne ; Greenough, Anne ; Wijnen, René M. ; Tibboel, Dick ; Reiss, Irwin K M ; Di Pede, Alessandra ; Dotta, Andrea ; Bagolan, Pietro ; Kraemer, Ulrike ; Pinto, Carla ; Silva, Maria Gorett ; Saldanha, Joana ; Bhat, Prashanth ; Murthy, Vadivelam ; Van Heijst, Arno ; Schaible, Thomas ; Wessel, Lucas ; Allegaert, Karel ; Debeer, Anne. / Conventional mechanical ventilation versus high-frequency oscillatory ventilation for congenital diaphragmatic hernia. A randomized clinical trial (The VICI-trial). In: Annals of Surgery. 2016 ; Vol. 263, No. 5. pp. 867-874.
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T1 - Conventional mechanical ventilation versus high-frequency oscillatory ventilation for congenital diaphragmatic hernia. A randomized clinical trial (The VICI-trial)

AU - Snoek, Kitty G.

AU - Capolupo, Irma

AU - Van Rosmalen, Joost

AU - De Jongste-Van Den Hout, Lieke

AU - Vijfhuize, Sanne

AU - Greenough, Anne

AU - Wijnen, René M.

AU - Tibboel, Dick

AU - Reiss, Irwin K M

AU - Di Pede, Alessandra

AU - Dotta, Andrea

AU - Bagolan, Pietro

AU - Kraemer, Ulrike

AU - Pinto, Carla

AU - Silva, Maria Gorett

AU - Saldanha, Joana

AU - Bhat, Prashanth

AU - Murthy, Vadivelam

AU - Van Heijst, Arno

AU - Schaible, Thomas

AU - Wessel, Lucas

AU - Allegaert, Karel

AU - Debeer, Anne

PY - 2016

Y1 - 2016

N2 - Objectives: To determine the optimal initial ventilation mode in congenital diaphragmatic hernia. Background: Congenital diaphragmatic hernia is a life-threatening anomaly with significant mortality and morbidity. The maldeveloped lungs have a high susceptibility for oxygen and ventilation damage resulting in a high incidence of bronchopulmonary dysplasia (BPD) and chronic respiratory morbidity. Methods: An international, multicenter study (NTR 1310), the VICI-trial was performed in prenatally diagnosed congenital diaphragmatic hernia infants (n = 171) born between November 2008 and December 2013, who were randomized for initial ventilation strategy. Results: Ninety-one (53.2%) patients initially received conventional mechanical ventilation and 80 (46.8%) high-frequency oscillation. Forty-one patients (45.1%) randomized to conventional mechanical ventilation died/had BPD compared with 43 patients (53.8%) in the high-frequency oscillation group. An odds ratio of 0.62 [95% confidence interval (95% CI) 0.25-1.55] (P = 0.31) for death/BPD for conventional mechanical ventilation vs highfrequency oscillation was demonstrated, after adjustment for center, head-lung ratio, side of the defect, and liver position. Patients initially ventilated by conventional mechanical ventilation were ventilated for fewer days (P = 0.03), less often needed extracorporeal membrane oxygenation support (P = 0.007), inhaled nitric oxide (P=0.045), sildenafil (P=0.004), had a shorter duration of vasoactive drugs (P = 0.02), and less often failed treatment (P = 0.01) as compared with infants initially ventilated by high-frequency oscillation. Conclusions: Our results show no statistically significant difference in the combined outcome of mortality or BPD between the 2 ventilation groups in prenatally diagnosed congenital diaphragmatic hernia infants. Other outcomes, including shorter ventilation time and lesser need of extracorporeal membrane oxygenation, favored conventional ventilation.

AB - Objectives: To determine the optimal initial ventilation mode in congenital diaphragmatic hernia. Background: Congenital diaphragmatic hernia is a life-threatening anomaly with significant mortality and morbidity. The maldeveloped lungs have a high susceptibility for oxygen and ventilation damage resulting in a high incidence of bronchopulmonary dysplasia (BPD) and chronic respiratory morbidity. Methods: An international, multicenter study (NTR 1310), the VICI-trial was performed in prenatally diagnosed congenital diaphragmatic hernia infants (n = 171) born between November 2008 and December 2013, who were randomized for initial ventilation strategy. Results: Ninety-one (53.2%) patients initially received conventional mechanical ventilation and 80 (46.8%) high-frequency oscillation. Forty-one patients (45.1%) randomized to conventional mechanical ventilation died/had BPD compared with 43 patients (53.8%) in the high-frequency oscillation group. An odds ratio of 0.62 [95% confidence interval (95% CI) 0.25-1.55] (P = 0.31) for death/BPD for conventional mechanical ventilation vs highfrequency oscillation was demonstrated, after adjustment for center, head-lung ratio, side of the defect, and liver position. Patients initially ventilated by conventional mechanical ventilation were ventilated for fewer days (P = 0.03), less often needed extracorporeal membrane oxygenation support (P = 0.007), inhaled nitric oxide (P=0.045), sildenafil (P=0.004), had a shorter duration of vasoactive drugs (P = 0.02), and less often failed treatment (P = 0.01) as compared with infants initially ventilated by high-frequency oscillation. Conclusions: Our results show no statistically significant difference in the combined outcome of mortality or BPD between the 2 ventilation groups in prenatally diagnosed congenital diaphragmatic hernia infants. Other outcomes, including shorter ventilation time and lesser need of extracorporeal membrane oxygenation, favored conventional ventilation.

KW - Congenital diaphragmatic hernia

KW - Conventional mechanical ventilation

KW - High-frequency oscillation

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